Effectiveness of a Wearable Device-based Assisted Post-stroke Rehabilitation System

NCT04997408 | Completed

• 1 other identifier: MOHW105-TDU-M-212-122008
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multidisciplinary rehabilitation facilitates functional recovery after stroke, and adherence to rehabilitation guidelines is associated with improved outcomes. We assessed the efficacy of a wearable device-assisted rehabilitation system in addition to conventional therapy compared to conventional therapy alone. A total of 127 eligible acute stroke inpatients were enrolled. There were 76 males (59.8%). The mean age of the participants was 57.45 years; 63 and 64 participants were randomized to the WG and CG, respectively. Both groups showed significant improvements in mRS scores at 90 days (WG: -0.68 \[95% confidence interval (CI), -0.94 to -0.42\]; CG: -0.56 \[95% CI, -0.74 to -0.38\]; P\<0.0001), but only the WG had significant improvements between 30 and 90 days (-0.36; 95% CI, -0.72, -0.007; P=0.049). Both groups had significant improvements in secondary outcomes at 90 days, but there was no difference between groups.

Conditions

Post-Acute-Stroke Rehabilitation

Keywords

Rehabilitation; Stroke; Mobile devices; Telemedicine

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale

  The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale, a global seven-level measure of functioning in which scores of 0 or 1 indicate a good outcome with no or minimal neurologic symptoms, scores of 2 to 5 indicate a poor outcome with increasing degree of disability, and 6 indicates death.

  Baseline, 30 days and 90 days

Secondary Outcomes (4)

• Change in Barthel Index (BI) at 30 days, 90 days

  Baseline, 30 days and 90 days

• Change in upper limb (UL) function (Stream Wolf Motor Function Test)

  Baseline, 30 days and 90 days

• Change in functional status (Functional Independence Measure)

  Baseline, 30 days and 90 days

• Change in static and dynamic balance ability (Berg balance scale)

  Baseline, 30 days and 90 days

Study Arms (2)

Study Arm

ACTIVE COMPARATOR

Mobile device-assisted rehabilitation

Device: Customized exercise app; Other: In-person therapist-supervised rehabilitation

Control Arm

ACTIVE COMPARATOR

In-person therapist-supervised rehabilitation

Other: In-person therapist-supervised rehabilitation

Interventions

Customized exercise app DEVICE

A Wearable Device-Based Assisted Post-Stroke Rehabilitation system

Study Arm

In-person therapist-supervised rehabilitation OTHER

In-person therapist-supervised rehabilitation

Control Arm; Study Arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide signed informed consent prior to study entry and understand the nature of this study and agree to adhere to all study protocol requirements.
• Males and females 20-75 years of age at the time of signing the informed consent
• Patients with first-ever acute ischemic or hemorrhagic stroke diagnosed by a neurologist or neurosurgeon within 4-12 weeks of onset,
• A baseline modified Rankin Scale score 2-4 on enrollment,
• A designated caregiver for each patient willing to assist the patient to be engaged in WEAR using the mobile embedded with APP.

You may not qualify if:

• Planning to have further rehabilitation in other hospital and could be followed up in the participating hospital.
• The caregiver of patients not willing to assist patients to be engaged in WEAR.

Sponsors & Collaborators

• Landseed Hospital: lead
• National Central University, Taiwan: collaborator
• Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital, Taiwan: collaborator
• Ministry of Health and Welfare, Taiwan: collaborator

Related Publications (1)

• Ho HJ, Wu LC, Wu EH, Lee SF, Lee TH, Chiang SH, Chen CH, Chen HY, Pan SJ, Chen YW; WEAR-Stroke Study Group. Improving patient outcomes in acute and subacute stroke using a wearable device-assisted rehabilitation system: a randomized controlled trial. J Int Med Res. 2024 Oct;52(10):3000605241281425. doi: 10.1177/03000605241281425.

  PMID: 39387211 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized study

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 9, 2021
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: April 1, 2018
• Last Updated: May 17, 2022

Record last verified: 2022-05